Covid 19 Clinical Trials

The COVID -19 pandemic has reduced endoscopy services to an average of 83% producing a significant economic impact on endoscopy units worldwide. Endoscopy as an aerosol-generating procedure requires endoscopy units to allow 12 cycles of air exchange per hour, equivalent to 20 minutes, between patients, to reduce medical risk exposure. Planning strategies to facilitate economic reactivation of endoscopy services in a responsible manner, maintaining adequate security measures for both patients and healthcare personnel is currently a major challenge. Serial endoscopic interventions as esophagogastroduodenoscopy (EGD) and colonoscopy are commonly performed during the same sedation time. Estimated times for quality inspection in the upper digestive tract and the colon, are 7 and 6 minutes, respectively. In addition, time to reach the cecum and to set up the following procedure increase not only procedure time but SARS-CoV-2 exposure to healthcare personnel. Performing these two procedures simultaneously by two endoscopists would considerably reduce procedure time while increasing the number of patients evaluated in one day, especially in the period of service reactivation. There are no studies comparing simultaneous EGD and colonoscopy procedures and, serial procedures. This study aims to determine differences in procedures times between simultaneous EGD-colonoscopy and conventional serial EGD-colonoscopy as an alternative to improve the number of procedures/hour/unit during the COVID-19 era.

NCT04473456 Procedure Time Procedure: Simultaneous EGD and colonoscopy

Primary Outcomes

Description: Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.

Measure: Procedures time

Time: Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.

Description: Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)

Measure: Interprocedure time

Time: Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)

Description: Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.

Measure: Upper GI inspection time

Time: Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.

Description: Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa

Measure: Colonoscopy withdrawal time

Time: Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa

Description: Time elapsed in minutes to reach the cecum

Measure: Colonoscopy insertion time

Time: Time elapsed in minutes to reach the cecum

Description: Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth

Measure: EGD time

Time: Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth

Description: Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum

Measure: Colonoscopy time

Time: Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum

Description: Amount in mg of Propofol used during EGD

Measure: Propofol used in EGD

Time: Amount in mg of Propofol used during EGD

Description: Amount in mg of Propofol used during colonoscopy

Measure: Propofol used in colonoscopy

Time: Amount in mg of Propofol used during colonoscopy

Description: Amount of Propofol in mg used fro procedures in the simultaneous arm.

Measure: Propofol used in EGD and colonoscopy

Time: Amount of Propofol in mg used fro procedures in the simultaneous arm

Description: Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.

Measure: percutaneous pCO2

Time: Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.

Description: Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.

Measure: percutaneous pO2

Time: Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.

Description: Change of patient's position during colonoscopy. Yes or No answer

Measure: Position change 1

Time: During colonoscopy

Description: If occurred, how many times the position changed. Numerical variable.

Measure: Position change 2

Time: During olonoscopy

Description: Nausea, drowsiness, and dizziness are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).

Measure: Post procedure symptoms survey related to colonoscopy

Time: 20 minutes after the last procedure and after 24 hours

Description: Abdominal pain, bloating, and pharyngeal pain are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).

Measure: Post procedure symptoms survey related to sedation

Time: 20 minutes after the last procedure and after 24 hours

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (1)

Correlated MeSH Terms (1)

Correlated HPO Terms (0)

Clinical Trials

1 Combined Simultaneous EGD-colonoscopy (CoSi Endoscopy) Harmlessly Reduces Procedure Times: a Randomized Control Trial

NCT04473456 Procedure Time Procedure: Simultaneous EGD and colonoscopy

Primary Outcomes

No related HPO nodes (Using clinical trials)